Feasibility Study of LUM Imaging System for Pancreatic Cancer

Trial details

Who runs it

Lumicell, Inc.

Trial code

NCT04276909

Record updated

2024. március 13.

Original description

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.Read full original descriptionShow less

Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

Inclusion: Subjects must have histological or cytological confirmation of pancreatic cancer on a biopsy prior to the operation with planned surgical resection. Subjects at any cancer stage will be enrolled; Age of 18 years or older; Subjects must be able and willing to follow study procedures and instructions; Subjects must have received and signed an informed consent form; Subjects must be otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below; Subjects must have normal organ and marrow function as defined below:; Leukocytes > 3,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal; Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal; Subjects with ECOG performance status of 0 or 1.

Exclusion: Subjects who have taken an investigational drug within 30 days of enrollment; Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy; History of allergic reaction attributed to drugs containing polyethylene glycol (PEG); History of allergic reaction to any oral or intravenous contrast agents; Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements; HIV-positive individuals on combination antiretroviral therapy are ineligible; Subjects with QT interval > 470 ms; Subjects who are pregnant or nursing at the time of diagnosis; Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015; Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents; Any subject for whom the investigator feels participation is not in the best interest of the subject.

ClinicalTrials.gov NCT04276909